CN104739502A - Method And Apparatus For Tissue Ablation - Google Patents

Method And Apparatus For Tissue Ablation Download PDF

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Publication number
CN104739502A
CN104739502A CN201510088183.1A CN201510088183A CN104739502A CN 104739502 A CN104739502 A CN 104739502A CN 201510088183 A CN201510088183 A CN 201510088183A CN 104739502 A CN104739502 A CN 104739502A
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setting element
conduit
steam
tissue
medium
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CN104739502B (en
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维兰德·K·沙马
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/24—Surgical instruments, devices or methods, e.g. tourniquets for use in the oral cavity, larynx, bronchial passages or nose; Tongue scrapers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00022—Sensing or detecting at the treatment site
    • A61B2017/00084—Temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00005—Cooling or heating of the probe or tissue immediately surrounding the probe
    • A61B2018/00011—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids
    • A61B2018/00029—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids open
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00273—Anchoring means for temporary attachment of a device to tissue
    • A61B2018/00279—Anchoring means for temporary attachment of a device to tissue deployable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00482—Digestive system
    • A61B2018/00488—Esophagus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577—Ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00642—Sensing and controlling the application of energy with feedback, i.e. closed loop control
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00791—Temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B2018/044—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating the surgical action being effected by a circulating hot fluid
    • A61B2018/048—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating the surgical action being effected by a circulating hot fluid in gaseous form
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/04—Constructional details of apparatus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/103—Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/107—Measuring physical dimensions, e.g. size of the entire body or parts thereof
    • A61B5/1076—Measuring physical dimensions, e.g. size of the entire body or parts thereof for measuring dimensions inside body cavities, e.g. using catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/04—Liquids
    • A61M2202/0468—Liquids non-physiological
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3331—Pressure; Flow
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3368—Temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1011—Multiple balloon catheters

Abstract

The present invention relates to a method and an apparatus for tissue ablation, is directed toward a device that performs ablation of tissue. The device has a catheter with a shaft through which an ablative agent can travel, a first positioning element attached to the catheter shaft at a first position and a second positioning element attached to the catheter shaft at a second position. The shaft also has ports through which the ablative agent can be released.

Description

For the method and apparatus of ablation of tissue
The application is the applying date is on October 06th, 2009, and application number is 200980148816.6, and denomination of invention is the divisional application of the application of " method and apparatus for ablation of tissue ".
Technical field
The present invention relates to a kind of medical apparatus and instruments and manufacture method thereof, the present invention relates more specifically to a kind of device for melting the tissue in hollow organ, this device comprise center or positioning attachment this device is positioned to and treats the distance that resection organization remains consistent.
Background technology
In crowd more than 50 years old, the people of 25% is almost had all to suffer from polyp of colon.Although most polyp is all found by colonoscopy and can be removed easily by snare, but, use snare technology to be difficult to remove Sessile flat polyps, and there is the excessive risk as complication such as hemorrhage, perforation.In recent years, along with the development of imaging technique, more flat polyp is found.The polyp that endoscope can not melt needs to pass through surgical removal.Most of colon cancer all develops from polyp of colon, therefore for preventing colon cancer, and must by these polyps safety, excise up hill and dale.
Barrett esophagus is precancerous symptom, has in the American of gastroesophageal reflux disease (GERD) and has the people of 10-14% to have this symptom, and has been proved to be the infringement in early stage of adenocarcinoma of esophagus, is the fastest cancer that rises in developed country.The incidence rate of cancer has increased 6 times over the last couple of decades, and mortality rate increases 7 times.5 annual death rate of esophageal carcinoma are 85%.Research shows that melting barrett's epithelium cell can prevent it from developing into esophageal carcinoma.
The women of child-bearing age of 30% suffer from dysfunctional uterine bleeding (DUB), or menorrhagia.These symptoms have impact on the Health and Living quality of women widely.This situation is normally treated by endometrial resection or hysterectomy.Perform the operation in these women get involved ratio very high.Almost the American Women's of 30% all can suffer from hysterectomy 60 years old time, and wherein the women of 50-70% is the operation done because of menorrhagia or dysfunctional uterine bleeding.FDA (food and FAD) has confirmed that endometrectomy is effective with the muscular tumor being less than 2cm for the improper metrorrhagia of women.Show, the appearance of submucous myoma and Enlarged uteri size reduce effect of standard uterus Endometrectomy.Five kinds of FDA accreditation global device for excising (namely, uterus thermal sphering treatment system, hot water perfusion, Nuo Shu, Her Option and microwave techniques) in, only have microwave techniques (MEA) to be proved for being less than 3cm and the submucous myoma of not closed endometrial cavity, and the large uterus to 14cm is effective.
The ablation method of known Barrett esophagus comprises laser therapy (Ertan etc., Am.J.Gastro., 90-2201-2203 [1995]), ultrasonic ablation (Bremner etc., Gastro.Endo., 43:6 [1996]), utilize light dynamic property therapy (the PDT) (Overholt etc. of photosensitizer, Semin.Surq.Oncol., 1:372-376 (1995)), utilize the multipolar electrocoagulation method (Sampliner etc.) of Bicap probe etc., argon plasma coagulation (APC; ), radio-frequency (RF) ablation (Sharma etc., Gastrointest Endosc) and cryoablation method (Johnston etc., Gastrointest Endosc).Endoscope and through endoscope passage or treat under the help of the device of endoscope.
But there are some intrinsic defects in conventional technology, is not widely used clinically.First, most hand-held ablating device (Bicap probe, APC, cryoablation method) be all produce little melt focus focus (point and shoot) device.This melts mechanism and depends on operator, trouble and consuming time.The second because destination organization because of patient move, respiratory movement, normal creepage of gastrointestinal functions and vascular pulsation and move, thus the depth of ablation of destination organization is inconsistent, can produce uneven melting.Melting of surface can produce halfway melting, and is stayed by the tumor tissues of remnants.And darker melt result can produce hemorrhage, form the complication such as narrow and perforation.In conventional equipment, these shortcomings and complication were all reported.
Such as, radio-frequency (RF) ablation utilizes the bipolar balloon electrode of rigidity and heat radiofrequency.Carry heat energy by directly being contacted with ill Barrett esophagus by electrode, can relatively uniformly, large-arealy to melt.But rigid electrode is not suitable with the change of esophagus size, therefore for melting bending esophagus, there is no effect as the esophagus of the near-end esophagus pathological changes narrowed towards top and gastrointestinal joint because of the change of esophagus diameter.Warty disease in Barrett esophagus can not utilize rigidity bipolar radio-frequency electrode to treat.Due to its size and rigidity, electrode can not pass this scope.In addition, slough tissue can hinder the conveying of radio-frequency (RF) energy to the adhesive attraction of electrode, thus can produce incomplete melting.Electrode size is limited to 3cm, thus needs repeatedly to apply when processing and having the Barrett esophagus of greater depth.
Photodynamic therapy (PDT) is two steps of separating, and comprises the photosensitizer injected by tumor and preneoplastic tissue resorption and reservation.Then by this tissue exposure in the light of selected wavelength, activate photosensitizer and also destroy this tissue.PDT can bring and form the complication such as narrow, and its heliosensitivity is only limitted to the acme being used in disease.In addition, the irregular absorption of photosensitizer produces incomplete melting and remaining tumor tissues.
Carry out directly contacting the research (Rodgers etc., Cryobiology, the 22:86-92 (1985) that esophageal tissue are carried out to cryoablation with liquid nitrogen with the mankind to animal model; Rodgers etc., Ann.Thorac.Surq.55:52-7 [1983]), and be used for treating Barrett esophagus (Johnston etc., GastrointestEndosc) and early esophageal cancer (Grana etc., Int.Surg., 66:295 [1981]).The injection catheter of the Barrett tissue that direct injection liquid nitrogen or carbon dioxide (cryoablation) or argon (APC) melt in esophagus is illustrated.There is the shortcoming of conventional hand-held device in these technology.Use this probe to carry out treatment cumbersome, and need operator to carry out control operation by directly observing endoscope.Esophagus because to breathe or the continuous moving of heart or arterial pulsatile or motion can cause and melts medium and be distributed unevenly, and produces uneven and/or incomplete melting.Conduit effects on surface epithelial near or directly contact can cause darker tissue injury, produce perforation, hemorrhage or formed narrow.Because esophagus moves, conduit is too far arranged, incomplete Barrett can be produced and melt, need repeatedly treatment time or cover damage, there is the continuous risk of esophageal carcinoma.In esophagus, the expansion of cryogenic gas can bring not quenchable nauseating, may produce esophagus and tears or bore a hole, thus need continuous sucking cryogen.
Usually utilize snare excision, use simultaneously or do not use monopolar cautery, excising polyp of colon.After carrying out snare excision, argon plasma cohesion or laser is utilized to treat flat polyp or remaining polyp.These two kinds of Therapeutic Method, have above-mentioned defect.Therefore, most of flat polyp need experience surgical resection, excises or ablation techniques has hemorrhage, perforation and the excessive risk of Residual Disease owing to utilizing conventional endoscope.
Traditionally for most of conventional balloon conduit of ablation of tissue, to air bag itself or be arranged on the heating element heaters such as radio frequency (RF) coil on air bag and heat or cool.This need balloon catheter with melted surface directly contact.When balloon catheter reduces, Epithelial Cell Adhesion is on conduit and remove, and thus produces hemorrhage.The conveying of blood meeting interfering energy, namely reduces energy.In addition, the application again of energy can produce darker burning to the region of the surperficial lining come off.And, balloon catheter can not be utilized to treat non-cylindrical organ, as uterus or nasal sinuses, and the on-circular shape in hollow organ or focus can not be provided to melt.In addition, if use exponentially expand after the heating as the cryogen melting medium, then balloon catheter may produce closed cavity and capture the cryogen of effusion, produces and such as bores a hole and to tear etc. complication.
Therefore, this area needs a kind of for melting the method and system of medium transport to the improvement of tissue surface, to provide continuous, controlled for destination organization and to melt uniformly, and reduces and will melt the unfavorable effect brought of medium importing patient.
Summary of the invention
The present invention relates to a kind of device that endometrial tissue is melted, comprising: conduit, there is the axle melting medium and can pass through; Be connected to the first setting element of described conduit axle in primary importance, wherein said first setting element is configured to described conduit to be positioned at Cervical central authorities between two parties; And be connected to the second setting element of described conduit axle in the second position, wherein said axle comprises multiple port, described in melt medium and can be discharged from described axle by described port, and wherein said port is between described primary importance and the second position.
Alternatively, the first setting element is taper.First setting element comprises dielectric film, and this dielectric film can be configured to prevent heat energy from being overflowed by cervix uteri.Second setting element is dish type.Second setting element has the size that can be used for determining cavity of uterus size.Second setting element has the size of the amount that can be used for calculating the heat energy melted needed for endometrial tissue.This device also comprises at least one temperature sensor, melts the conveying of medium for controlling steam etc.
Alternatively, the second setting element separates the distance that endometrial tissue to be ablated is greater than 0.1mm.First setting element is insulation (covered) gauze.First setting element is the round with 0.1mm-10cm diameter.Second setting element is oval, and wherein said ellipse has the major axis of 0.1mm-10cm and the minor axis of 0.1mm-5cm.
In another embodiment, the present invention relates to a kind of device melted endometrial tissue, comprising: conduit, having can the quill shaft of delivering vapor; Be connected to the first setting element of described conduit axle in primary importance, wherein said first setting element is taper and is configured to make described conduit be centrally placed in Cervical central authorities; The second setting element of described conduit axle is connected in the second position, wherein said second setting element is dish type, multiple port is formed on conduit axle, wherein steam can be released from port and the endometrial tissue that leads, and wherein said port is between primary importance and the second position; With at least one temperature sensor.
Alternatively, the second setting element has the size that can be used for determining cavity of uterus size.Second setting element has the size that can be used for calculating the amount melting heat energy needed for endometrial tissue.Temperature sensor is for melting the conveying of medium described in controlling.First setting element comprises gauze.Second setting element is oval dish, and ellipse has the major axis of 0.1mm-10cm and the minor axis of 0.1mm-5cm.
To the device that the tissue in hollow organ melts, comprising: conduit, there is the axle melting medium and can pass therethrough; Be connected to the first setting element of the axle of described conduit in primary importance, wherein said first setting element is configured to described catheter positioning in organizing preset distance place apart to be ablated; Wherein said axle comprises one or more port, described in melt medium and can be discharged from described axle by described port.
Alternatively, this device is also included in the second setting element that the position being different from described first setting element is connected to described conduit axle.First setting element is taper, dish type, or at least one in the free forming shape suitable with the shape of hollow container.Second setting element has preliminary dimension, and wherein said preliminary dimension is for determining the size of hollow organ to be ablated.First setting element comprises dielectric film, and this dielectric film is configured to prevent heat energy from overflowing.This device also can comprise at least one in sound, electromagnetism, infrared ray or radio-frequency (RF) energy sensor, and wherein said sensor is for measuring the size of hollow organ.Second setting element is taper, dish type, or at least one in the free forming shape suitable with the shape of hollow container.Second setting element has preliminary dimension, and wherein said preliminary dimension is for determining the size of hollow organ to be ablated.Second setting element has preliminary dimension, and wherein said preliminary dimension is for calculating the amount of heat energy needed for ablation tissue.This device also comprises at least one temperature sensor.Temperature sensor is for melting the conveying of medium described in controlling.The described medium that melts is steam.First setting element is insulation gauze.First setting element comprises the round with 0.01mm-10cm diameter.First setting element is oval, and wherein said ellipse has the major axis of 0.01mm-10cm, and the minor axis of 0.01mm-9cm.
In another embodiment, the present invention relates to a kind of device melted the tissue in hollow organ, comprising: conduit, having can the quill shaft of delivering vapor; Be connected to the first setting element of described conduit axle in primary importance, wherein said first setting element is configured to described catheter positioning to the position apart from hollow organ surface preset distance; Be connected to the second setting element of described conduit axle in the second position, the shape of wherein said second setting element is configured to described catheter positioning to the position apart from hollow organ surface preset distance; Be integrally formed in the multiple ports on described conduit axle, wherein steam can be released from described port and the tissue to be ablated that leads, and wherein said port is between described primary importance and the described second position; With at least one temperature sensor.
Alternatively, the first setting element has preliminary dimension, and wherein said size is for determining the size of hollow organ to be ablated.Second setting element has preliminary dimension, and wherein said size is for calculating the amount of the heat energy needed for ablation tissue.Temperature sensor is for melting the conveying of medium described in controlling.First setting element comprises gauze.Second setting element has oval dish type, and wherein said ellipse has the major axis of 0.01mm-10cm, and the minor axis of 0.01mm-9cm.
In another embodiment, the present invention relates to a kind of device that gastrointestinal tissue is melted, comprising: conduit, there is the axle melting medium and can pass through; The first setting element of described conduit axle is connected in primary importance, wherein said first setting element is configured to by described catheter positioning in apart from fixed range place of gastrointestinal tissue to be ablated, and wherein said first setting element leaves the distance of ablation areas 0mm-5cm; Be positioned at the second position and be communicated with described conduit axial flow body to receive described in melt the inlet of medium, wherein said axle comprises one or more port, described in melt medium and can be discharged from described axle by described port.
Alternatively, the first setting element is at least one in aerating gasbag, gauze or cone.By importing in described ablation areas by the described medium that melts, device produces the gastrointestinal stress being equal to or less than 5atm.Melt the temperature that medium has-100-200 degree Celsius.Conduit also comprises temperature sensor.Conduit also comprises pressure transducer.First setting element is configured to connect gastrointestinal contact when being arranged in stomach cardia.Port is between described primary importance and the second position.The diameter of setting element is within the scope of 0.01mm-100mm.Melting medium is steam.First setting element comprises the round with 0.01mm-10cm diameter.
In another embodiment, the present invention relates to a kind of device melted esophageal tissue, comprising: conduit, having can the quill shaft of transit steam; Be connected to the first setting element of described conduit axle in primary importance, wherein said first setting element is configured to connect gastrointestinal contact when being arranged in stomach cardia; And being communicated with described conduit axial flow body the input port receiving described steam medium in the second position, wherein said axle comprises multiple port, described steam can be discharged from described axle by described port.Wherein said port is between described primary importance and the second position.This device also comprises temperature sensor, and wherein said temperature sensor is for controlling the release of described steam.First setting element comprises gauze dish, gauze taper, or at least one in aerating gasbag.First setting element separates ablation areas 0mm-1cm distance.The diameter of the first setting element is between 1mm and 100mm.
In another embodiment, the present invention relates to a kind of device melted gastrointestinal tissue, comprising: conduit, having can the quill shaft of transit steam; Be connected to the first setting element of described conduit axle in primary importance, wherein said first setting element is configured to connect gastrointestinal contact; And be positioned at the second position and be communicated with to receive the input port of described steam with described conduit axial flow body, wherein said axle comprises one or more port, and described steam can be discharged into described gastrointestinal tissue by described port from described axle.
Alternatively, this device also comprises temperature sensor, and wherein said temperature sensor is for controlling the release of described steam.First setting element comprises at least one in gauze dish and gauze taper.The diameter of the first setting element is 0.1mm-50mm.This device is used for carrying out on-circular shape and melts.
In another embodiment, the present invention relates to a kind of device that endometrial tissue is melted, comprising: conduit, there is the axle melting medium and can pass through; Be connected to the first setting element of described conduit axle in primary importance, wherein said first setting element is configured to described conduit to be positioned at Cervical central authorities between two parties; Axle comprises multiple port, described in melt medium and can be discharged from described axle by described port.
Alternatively, this device is also included in the second setting element that the second position is connected to described conduit axle.First setting element is taper.First setting element comprises dielectric film, and this dielectric film is configured to prevent heat energy from overflowing via cervix uteri.Second setting element dish type.Second setting element has preliminary dimension, and wherein said size is for determining the size of cavity of uterus.Second setting element has preliminary dimension, and wherein said size melts the amount of heat energy needed for endometrial tissue for calculating.This device also comprises at least one temperature sensor, and wherein said temperature sensor is for melting the conveying of medium described in controlling.The described medium that melts is steam.First setting element is insulation gauze.First setting element comprises the round with 0.01mm-10cm diameter.Second setting element is oval, and wherein said ellipse has the major axis of 0.01mm-10cm, and the minor axis of 0.01mm-5cm.
In another embodiment, the present invention relates to a kind of device that endometrial tissue is melted, comprising: conduit, there is the quill shaft that steam can be carried; Be connected to the first setting element of described conduit axle in primary importance, wherein said first setting element is taper, and is configured to described conduit to be positioned at Cervical central authorities between two parties; Be connected to the second setting element of described conduit axle in the second position, wherein the second setting element is oval; Be integrally formed in the multiple ports on described conduit axle, wherein steam can be discharged from described axle by described port and lead endometrial tissue, and wherein said port is between described primary importance and the second position; With at least one temperature sensor.
Alternatively, the second setting element has preliminary dimension, and wherein said size is for determining the size of cavity of uterus.Second setting element has diameter, and wherein said diameter is for calculating the amount of the heat energy melted needed for endometrial tissue.Temperature sensor is for melting the conveying of medium described in controlling.First setting element comprises gauze.Second setting element has oval dish type, and wherein said ellipse has the major axis of 0.01mm-10cm and the minor axis of 0.01mm-5cm.
Alternatively, the second setting element can use one or more sources in infrared ray, electromagnetism, sound or radio-frequency (RF) energy, measures the size of cavity.This energy launch from sensor and reflect back toward sensor in detector.Reflectance data can be used for the size determining cavity.
In another embodiment, the present invention relates to a kind of device that gastrointestinal tissue is melted, comprising: conduit, there is the axle melting medium and can pass therethrough; Be connected to the first setting element of the axle of described conduit in primary importance, wherein said first setting element is configured to described catheter positioning in apart from fixed range place of gastrointestinal tissue to be ablated; And melt the input port of medium described in being communicated with the axial flow body of described conduit to receive in second position, wherein said axle comprises one or more port, described in melt medium and can be discharged from described axle by described port.
Alternatively, this device also can comprise the second setting element of the axle being connected to described conduit, and wherein said port can between described primary importance and the described second position.
Accompanying drawing explanation
By embodiment illustrated in the accompanying drawings, the present invention is described, wherein
Fig. 1 illustrates the ablating device according to one embodiment of the present invention;
Fig. 2 A illustrates the longitudinal section with the ablating device of distribution openings on it;
Fig. 2 B illustrates the cross section with the ablating device according to one embodiment of the present invention of distribution openings on it;
Fig. 2 C illustrates the cross section according to the distribution openings on the ablating device of another embodiment of the present invention;
Fig. 2 D illustrates the conduit of the ablating device according to one embodiment of the present invention;
Fig. 3 A illustrates according to one embodiment of the present invention, is arranged in the upper gastrointestinal with Barrett esophagus selectively to melt the ablating device of Barrett tissue;
Fig. 3 B illustrates according to another embodiment of the present invention, is arranged in the upper gastrointestinal with Barrett esophagus selectively to melt the ablating device of Barrett tissue;
Fig. 3 C illustrates the flow chart used according to the basic procedure steps of the ablating device of one embodiment of the present invention;
Fig. 4 A illustrates according to one embodiment of the present invention, is arranged in colon to melt the ablating device of flat polyp of colon;
Fig. 4 B illustrates according to another embodiment of the present invention, is arranged in colon to melt the ablating device of flat polyp of colon;
Fig. 5 A illustrates the ablating device with coaxial pipe design according to one embodiment of the present invention;
Fig. 5 B illustrates the positioner of the local expansion according to one embodiment of the present invention;
Fig. 5 C illustrates the positioner launched completely according to one embodiment of the present invention;
Fig. 5 D illustrates the ablating device with taper setting element according to one embodiment of the present invention;
Fig. 5 E illustrates the ablating device with dish type setting element according to one embodiment of the present invention;
Fig. 6 illustrates upper gastrointestinal, wherein treats this hemorrhage vascular pathological changes according to the ablating device of one embodiment of the present invention;
Fig. 7 illustrates the endometrial ablation utilizing and perform womb according to the ablating device of one embodiment of the present invention;
Fig. 8 illustrates to utilize and melts the hole that nasal passage performs according to the ablating device of one embodiment of the present invention;
Fig. 9 illustrates melting of the bronchus that utilizes and perform pulmonary system according to the ablating device of one embodiment of the present invention and bulla;
Figure 10 illustrates the ablation of prostate utilizing and perform the increase prostate in male reproductive system according to the ablating device of one embodiment of the present invention;
Figure 11 illustrates to utilize and melts the fibroma uteri that womb performs according to the ablating device of one embodiment of the present invention;
Figure 12 illustrates the steam transmission system utilizing radio heater for the ablating device delivering vapor according to one embodiment of the present invention; With
Figure 13 illustrates the steam transmission system utilizing resistance heater for the ablating device delivering vapor according to one embodiment of the present invention.
Detailed description of the invention
The invention provides a kind of ablating device, comprise conduit, have one or more centering or positioning attachment in one or more ends of conduit, to make conduit and inlet thereof be fixed on the position of distance ablation tissue fixed range, it can not be subject to the impact of organ movement.The layout of one or more jet allows the even injection of melting medium, produces melt uniformly large area such as such as Barrett esophaguses.Utilize microprocessor to control the flowing of melting medium, and depend on the length of tissue to be ablated or region, the type of tissue to be ablated and the degree of depth and to be organized into the distance of inlet one or more to be ablated.
" treatment " and distortion thereof refer to any degree, frequency in one or more symptom relevant with health status or omen, or the alleviating of intensity.
" persistent period " and distortion thereof refer to the cycle of prescribed treatment from start to end, and whether this treatment is because health status improves or treats because other reason stops and terminate.In the persistent period for the treatment of, can specify multiple treatment cycle, in these treatment cycle, performing one or more prescription to target stimulates.
" cycle " refers to the time stimulated target execution one " agent " as a prescribed treatment plan part.
Term "and/or" refers to any two or more combination in one or all element listed or institute's column element.
The term occurred in the specification and in the claims " comprises " and is out of shape, not the conditional meaning of tool.
Unless otherwise defined, " one ", " one or more " and " at least one " can exchange use, mean one or more.
For any method comprising concrete steps disclosed herein, these steps can be carried out with any feasible order.And, suitably, any combination of two or more step can be carried out simultaneously.
Meanwhile, at this, the enumerating of numerical range endpoint is included in all numerals (such as, 1-5 comprise 1,1.5,2,2.75,3,3.80,4,5 etc.) comprised within the scope of this.All can be revised by term " left and right " unless otherwise defined, all numerals such as expression component count, molecular weight used in the specification and in the claims all should be understood to be in all examples.Therefore, unless otherwise defined, the digital parameters mentioned in the specification and in the claims is all approximation, the estimated performance that will be able to obtain according to the present invention changes.Not the protection domain that doctrine of equivalents to be restricted to claim by intention at all, at least should according to the significant digits provided and the numeral using the common technology of rounding up to obtain explains each digital parameters.
Although numerical range and the parameter of the relative broad range of the present invention proposed are approximations, the numerical value proposed in a particular embodiment is accurate all as far as possible.But all numerical value is included in the scope that it tests the necessity produced from standard deviation found in measurement separately inherently.
Such as steam, heated air etc. melt medium, or such as, but not limited to cryogens such as liquid nitrogen, cheap and easily obtain, and import to tissue, keep fixing and continuous print distance, to melt via inlet.Such permission distributes on the target tissue with melting homogeneous media.Microprocessor according to preordering method and based on tissue to be ablated feature, need the degree of depth that melts, and from being organized into the distance of inlet, control the flowing of melting medium.Microprocessor can utilize temperature, pressure or other sensed data to control to melt the flowing of medium.In addition, arrange one or more pump orifice, near destination organization, medium is melted in suction.Medium can be melted by injecting continuously, or melt the circulation of medium by the injection determined by microprocessor and control and removal, target phase is treated.
It should be understood that device described here and embodiment are consistent with the microprocessor-based control device comprised for performing control command to perform.This controller can be any type of computer installation, comprises desktop, on knee and mobile device, and can be carried out the communication of control signal by wired or wireless form and ablating device.
What provide below is open to enable those of ordinary skill in the art realize the present invention.Those skilled in the art should be perfectly clear, and the illustrative embodiments provided just for purposes of illustration, can also carry out various distortion.Without departing from the spirit and scope of the present invention, ultimate principle defined in this can be applied in other embodiment and application.In addition, for describing the term that uses of illustrative embodiments and term should not be considered to have restriction.Thus, the present invention should be given and comprise the multiple modification consistent with disclosed principle and feature, improvement and the equivalent the widest protection domain replaced.In order to simplify, be not described in detail in the details of technologic material known in correlative technology field of the present invention, in order to avoid unnecessarily obscure the present invention.With reference now to the embodiment shown in accompanying drawing, content discusses the present invention.
Fig. 1 illustrates the ablating device according to one embodiment of the present invention.This ablating device comprises conduit 10, and it has end and centers or positioning attachment and inflatable bladders 11.Conduit 10 is made up of insulant or is covered by insulant, overflows from catheter body to prevent ablation energy.Ablating device comprises one or more for injecting the inlet 12 melting medium, and one or more for removing the pump orifice 13 melting medium.In one embodiment, inlet 12 and pump orifice 13 are identical.Melt media storage in the bin 14 being connected to conduit 10.The conveying of melting medium is controlled by microprocessor 15, and the startup for the treatment of is utilized the input equipment such as such as pedal to control by treating physician.In other embodiments, input equipment can be speech recognition system (responding to the such as order such as " beginning ", " more ", " less "), Genius mouse, switch, callosity (footpad), or other input equipment any known to persons of ordinary skill in the art.In one embodiment, microprocessor 15 is by the signal from input equipment, such as be placed in the pressure on pedal or provide " more " or " less " to melt the voice command of medium, be transformed into and determine whether to distribute more or less control signal melting medium.Ablation tissue monitored by selectable sensor 17 or the change near it melts medium stream to guide.The size of hollow tissue measured by selectable infrared ray, electromagnetism, sound or radio frequency energy emitter and sensor 18.
In one embodiment, inflatable bladders has the diameter of 1mm-10cm.In one embodiment, inflatable bladders can separate the distance of 1mm-10cm with port.In one embodiment, port openings is of a size of 1 μm of-1cm.It should be understood that and use inflatable bladders to fix device, be therefore configured to not contact with ablation areas.This inflatable bladders can have and any shape of hollow organ at 3 or more point cantact.Those of ordinary skill in the art utilize triangulation can calculate the distance damageeing conduit.Alternatively, infrared ray, electromagnetism, sound or radio frequency energy emitter and sensor 18 can measure the size of hollow organ.Infrared ray, electromagnetism, sound or radio-frequency (RF) energy from emitter 18 launch and from Tissue reflectance to emitter 18 detector.Reflectance data can be used to determine the size of cavity.It should be understood that emitter and sensor 18 can be merged into can either emitted energy again can detection of reflected can a transmitter receiver.
Fig. 2 A illustrates the longitudinal section of ablating device, and the distribution of inlet is shown.Fig. 2 B illustrates the cross-sectional view of the distribution according to the inlet on the ablating device of one embodiment of the present invention.Longitudinal section and the cross section of conduit 10 are shown in Fig. 2 A and 2b respectively, illustrate can uniform distribution melt the inlet 12 of medium 21 one configuration, to provide the ablation areas of circumferential in hollow organ 20.Fig. 2 C illustrates the cross-sectional view of the distribution of the inlet of the ablating device according to another embodiment of the present invention.The layout 12 of inlet shown in Fig. 2 C produces the focusing or focus distribution (focal distribution) and the focusing of melting in hollow organ 20 or focal area (focal area) of melting medium 21.
For all embodiments described herein, it should be understood that, the size of port, the number of port, and the size of the hollow organ that goes out of distance between port amount, pressure that hollow organ can bear, the range measurement from port to surface of melting medium by required, the length (being roughly surf zone to be ablated) of tissue to be ablated, tissue to be ablated characteristic sum needed for the degree of depth that melts decide.In one embodiment, having at least one diameter is 1 μm of-1cm port openings.In another embodiment, there are two diameters and be 1 μm of-1cm and the port openings of circumference spaced at equal intervals around this device.
Fig. 2 D illustrates another embodiment of ablating device.Steam ablation catheter comprises the insulated conduit 21 of one or more positioning attachments 22 with known length 23.Steam ablation catheter has one or more steam injection mouth 25.The length 24 with the steam ablation catheter 21 of inlet 25 is determined by the length of tissue to be ablated or region.Steam 29 is carried by steam injection mouth 25.Conduit 21 is preferably disposed in the center of positioning attachment 22, and inlet 25 is by circumferentially along the circumferential direction to melt and delivering vapor.In another embodiment, conduit 21 can be arranged towards the periphery of positioning attachment 22, non-ly circumferentially can arrange inlet 25, preferably be arranged in side linearly and melt and delivering vapor with Focal.Positioning attachment 23 is aerating gasbag, gauze dish, conical attachment, the annular attachment being with or without dielectric film covering above or is designed to be suitable for the one in the free forming adnexa of required hollow body organ or Hollow Body passage, hereafter can further describe.Optional infrared ray, electromagnetism, sound or radio frequency energy emitter and sensor 28 can be merged in, to measure the size of hollow organ.
Steam ablation catheter can also comprise optional coaxial thin plate (coaxial sheet) 27, to limit positioning attachment 22 in the mode similar with crown metal rack.In one embodiment, the memory metal or memory material coiled by having compression linear forms and uncompressed form positioning attachment shape is made.Alternatively, the passage of endoscope can by such as serving as confinement sleeve to perform the function of restriction positioning attachment.Optional sensor 26 is configured on conduit to measure with steam Transportation or to melt relevant change.Sensor is the one in temperature, pressure, image or chemical sensor.
Alternatively, infrared ray, electromagnetism, sound or radio frequency energy emitter and sensor 28 can measure the size of hollow organ.Infrared ray, electromagnetism, sound or radio frequency can emit and get back to the detector emitter 18 from Tissue reflectance from emitter 18.Reflectance data can be used to determine the size of cavity.The accurate estimation measuring to obtain hollow organ's size is carried out at one or more point.The topography image of hollow organ can also be produced by usage data.
Fig. 3 A illustrate according to one embodiment of the present invention be placed in there is Barrett esophagus upper gastrointestinal optionally to melt the ablating device of Barrett tissue.Upper gastrointestinal comprises Barrett esophagus 31, stomach cardia 32, stomach esophagus contact 33 and displacement squama post junction 34.Region between stomach esophagus contact 33 and displacement squama post junction 34 is the target Barrett esophagus 31 that will melt.The far-end of cardia 32 is stomaches 35, and the near-end of cardia 32 is esophaguses 36.Ablating device is through esophagus 36, and positioner 11 is arranged in stomach cardia 32 and connects stomach esophagus contact 33.The central authorities like this ablation catheter 10 and port one 2 thereof being fixed on esophagus 36 also allow to melt medium 21 and are transported to Barrett esophagus 31 equably.In one embodiment, before melting, being first fixed to by positioner is not in anatomical structure to be ablated.If patient carries out circumferential ablation or first time when melting, preferably positioning attachment is arranged in stomach cardia, connects stomach esophagus contact.Melt if patient is the focusing carrying out any Residual Disease, then preferably use the conduit system shown in Fig. 4 b, after can further describe.In one embodiment, positioning attachment must separate ablation areas more than 0mm, is 1mm best, is desirably the distance of 1cm.In one embodiment, the size of positioner, at 10-100mm, is preferably within the scope of 20-40mm, although it should be understood by one skilled in the art that accurate dimension depends on the size of esophageal patient.
Melt medium 21 to be controlled by the microprocessor 15 be connected with ablating device by the conveying of inlet 12.The conveying of melting depends on tissue to be ablated and required depth of ablation, is guided by preset program instruction.In one embodiment, target program temperature can need roughly-100-200 degree Celsius, is preferably 50-75 degree Celsius, can illustrate further in the form below.In one embodiment, esophagus pressure should be no more than 5atm, is preferably lower than 0.5atm.In one embodiment, less than in 1 minute, preferably obtaining target program temperature less than in 5 seconds, and can keep, up to 10 minutes, being preferably 1-10 second, being then cooled to body temp.Those of ordinary skill in the art can know can carry out repetitive therapy until obtain needed for ablation effect.
The arterial parameters such as optional sensor 17 monitoring temperature and pressure and can by inlet 12 increase or reduce melt medium 21 flowing to obtain enough heating or cooling, produce enough melting.The arterial parameters such as such as temperature and pressure monitored by sensor 17, can increase or reduce the removal amount melting medium 21 by optional pump orifice 13, to obtain enough heating or cooling, to carry out enough melting to Barrett esophagus 31.Fig. 3 b illustrate according to another embodiment of the present invention be placed in there is Barrett esophagus upper gastrointestinal optionally to melt the ablating device of Barrett tissue.As shown in Figure 3 b, positioner 11 is gauze dishes.In one embodiment, positioning attachment must separate more than 0mm with ablation areas, is preferably 1mm, is desirably the distance of 1cm.In one embodiment, positioning attachment be removably fixed on be positioned at Barrett tissue in cardia or EG interface (for distal attachment) or fixing esophagus roughly top above more than 0.1mm, be preferably about 1cm place (for near-end adnexa).
Another embodiment of Fig. 3 B to be setting element 11 be Barrett ablating device of gauze dish.Gauze can have optional dielectric film to prevent from melting medium effusion.In the present embodiment, use two gauze dishes that ablation catheter is positioned at esophagus central authorities.Distance between two dishes is determined by the length of tissue to be ablated, and in the case, this length is exactly the length of Barrett esophagus.Optional infrared ray, electromagnetism, sound or radio frequency energy emitter and sensor 18 can be merged in the diameter measuring esophagus.
Fig. 3 C is the flow chart that the basic procedure steps using ablating device according to one embodiment of the present invention is shown.In step 302, the conduit of ablating device is inserted in hollow organ to be ablated.Such as, in order to melt the Barrett esophagus of patient, conduit is inserted in Barrett esophagus via the esophagus of patient.
In step 304, the positioning attachment of ablating device is used.In one embodiment, if setting element is air bag, then air bag is inflated with the known preset distance place navigated to by ablating device apart from tissue to be ablated.The diameter of hollow organ both can be determined by using the such as radioactive test such as barium X-ray or computed tomography (CT) scanning, also can by using pressure volume circulation namely volume required with the fixing horizontal (such as 1atm) of air bag pressure being elevated to fixed volume by determining.In another embodiment, if positioner is dish type, then periphery ring is set to make the doctor of operation visually understand the diameter of hollow organ.In various embodiments of the present invention, positioner can make the conduit of ablating device placed in the middle in on-circular bodily cavity, and the volume in chamber is measured by the length of conduit or uterine sound.
Alternatively, one or more infrared ray, electromagnetism, sound or radio frequency energy emitter and sensor can be used to measure the size of hollow organ.Infrared ray, electromagnetism, sound or radio frequency can be launched from emitter and detector from Tissue reflectance to emitter.Reflectance data can be used to determine the size of cavity.Can carry out measuring at one or more point the accurate estimation obtained hollow organ's size.The data from multiple point can also be used to produce in official's organ topography image or be used for calculating the volume of hollow organ.
In one embodiment, positioning attachment must with more than port distance 0mm, being preferably and being greater than 0.1mm, is more preferably 1cm.The Size dependence of positioner in hollow organ to be ablated size and change from 1mm-10cm.In one embodiment, the diameter of setting element is 0.01mm-100mm.In one embodiment, the first setting element comprises the round with 0.01mm-10cm scope interior diameter.
Within step 306, by melting medium melt organ via being arranged on supravasal inlet automatic transport such as steam etc.Melt medium to be controlled by the microprocessor be connected with ablating device by the conveying of inlet.Melt the conveying of medium, depend on tissue to be ablated and the required degree of depth melted, guided by preset program instruction.In an embodiment of the invention, if melting medium is steam, then the dosage melting medium is determined by carrying out dosimetry research, to determine the dosage melting endometrial tissue.The variable can determining to melt medium accumulated dose is the volume (quality) of tissue to be treated, and it is by utilizing the diameter of the length of conduit and organ (for cylindrical shape organ) to calculate.What then utilize the steam generator of Microprocessor S3C44B0X to carry determined dosage melts medium.
In one embodiment, first determine treatment disease and expect tissue effect, then finding corresponding temperature, thus dosage is provided, as shown in the table:
In addition, the retention time of required depth of ablation determination maximum temperature.For surface ablation (Barrett), the retention time of maximum temperature is very short (rapid calcination), does not allow heat to be transported to more deep layer.The normal structure damaging bottommost layer can be prevented like this, therefore can prevent patient from not accommodating complication.For darker ablation of tissue, the retention time of maximum temperature can be more longer, and thus permission heat is permeated darker.
Fig. 4 A illustrates and is placed according to one embodiment of the present invention the ablating device that colon is used for melting flat polyp of colon.Ablation catheter 10 is through colonoscope 40.Positioner 11 is arranged in Normal Colon 42 near flat polyp of colon 41 to be ablated.The gauze dish that positioner 11 is aerating gasbags, with or without covers the dielectric film on it, taper attachment, annular attachment or be designed to be suitable for the one in the free forming adnexa of colonic lumen.Positioner 11 has conduit 10, towards the circumference of positioner 11, it is arranged to carry out melting of all shapes of non-week near polyp 41.Therefore, conduit is fixed in colon 42 spaced a predetermined distance from polyp 41 by positioner 11, melts medium 21 evenly also intensively to carry.Melt medium 21 to be controlled by the microprocessor 15 being connected to ablating device by the conveying of inlet 12, and depend on tissue and the required degree of depth melted.The conveying of melting medium 21 depends on tissue to be ablated and required region of melting and the degree of depth, is guided by preset program instruction.Ablating device allows carry out concentrated melting to ill polyp mucosa and do not damage the normal colon mucosa away from catheter port.
In one embodiment, positioning attachment must leave the distance that ablation areas is greater than 0.1mm, is desirably the distance more than 5mm.In one embodiment, setting element is close to polyp of colon.For this application, the embodiment shown in Fig. 4 B is preferred.
Fig. 4 B illustrates and is placed in colon to melt the ablating device of flat polyp of colon according to another embodiment of the present invention.As shown in Figure 4 B, positioner is the taper attachment being positioned at conduit top.Taper attachment has known length " l " and diameter " d ", for calculating the amount of the heat energy melted needed for flat polyp of colon.In one embodiment, positioning attachment must leave ablation areas and is greater than 0.1mm, is preferably 1mm, is more preferably the distance of 1cm.In one embodiment, length " l " is greater than 0.1mm, is preferably 5-10mm.In one embodiment, diameter " d " depends on the size of polyp, and can be 1mm-10cm, is preferred for 1-5cm.Present embodiment can also be used melt redundant tissue remaining on edge after endoscopic snare cuts away larger sessile polyp of colon.
Fig. 5 A illustrates the ablating device with coaxial pipe design according to one embodiment of the present invention.Coaxial design has handle 52a, inlet 53a, interior sheath 54a and epitheca 55a.Epitheca 55a is used for positioner 56a being limited in make position and surrounding port 57a.Fig. 5 B illustrates the positioner 56b that part is launched, and port 57b is still positioned at epitheca 55a.Positioner 56b is launched by pushing conduit 54b open part from sheath 55a.
Fig. 5 C illustrates the positioner 56c launched completely.Inlet 57c leaves sheath 55c.Comprise the length " l " of the conduit 54c of inlet 57c and the diameter " d " of setting element 56a is predetermined/known, for calculating the amount of required heat energy.Fig. 5 D illustrates the conical design of setting element.Setting element 56d is the taper with known length " l " and diameter " d ", and known length " l " and diameter " d " are for calculating the amount melting required heat energy.Fig. 5 e illustrates the dish-shaped design of setting element 56e, comprises circumferential ring 59e.Circumferential ring 59e is arranged at fixing preset distance place, and for the diameter of the hollow organ or hollow channel that estimate patient body.
Fig. 6 illustrates that the upper gastrointestinal with hemorrhage vascular lesion for the treatment of is carried out in utilization according to the ablating device of one embodiment of the present invention.Vascular lesion be bottom ulcer 62 in visible vascular 61.Ablation catheter 63 is through the passage of endoscope 64.Taper setting element 65 is arranged in above visible vascular 61.Taper setting element 65 has known length " l " and diameter " d ", for calculating for solidifying visible vascular with the amount of the required heat energy that stops blooding.The setting element of taper has optional dielectric film, prevents heat energy or steam from escaping from disease site.
In one embodiment, positioning attachment must leave ablation areas and is greater than 0.1mm, is preferably 1mm, is more preferably the distance of 1cm.In one embodiment, length " l " is greater than 0.1mm, is preferably 5-10mm.In one embodiment, diameter " d " depends on the size of pathological changes, can be positioned at 1mm-10cm scope, be preferably 1-5cm.
Fig. 7 illustrates the endometrial ablation using and carry out womb according to the ablating device of one embodiment of the present invention.Show the cross-sectional view of the female genital tract comprising bottom vagina 70, cervix uteri 71, uterus 72, endometrium 73, fallopian tube 74, sheath 75 and uterus 76.Conduit 77 transcervical 71 of ablating device inserts in uterus 72.In one embodiment, conduit 77 has two setting elements: taper setting element 78 and dish type setting element 79.Setting element 78 is tapers, has the dielectric film covering taper setting element 78.Conduit 77 is positioned at the central authorities of cervix uteri 71 by conical component 78, and dielectric film prevents from heat energy or melt medium being overflowed by cervix uteri 71.Second dish type setting element 79 launches near 76 bottom uterus, conduit 71 is positioned at the centre of cavity.Melt medium 778 by inlet 777, medium 778 will be melted and be transported to equably in cavity of uterus.The predetermined length " l " of the section of melting conduit and the diameter " d " of setting element 79 allow to estimate chamber size, and for calculating the amount melting endometrium lining heat energy.Alternatively, the temperature sensor 7 configured near endometrial surface can be used for the conveying controlling to melt medium 778.Alternatively, utilize multiple infrared ray, electromagnetism, mapping is taken a picture in the local of sound or radio frequency energy emitter and sensor, can be used for defining the shape of the size of cavity of uterus and the cavity of uterus of or distortion irregular because of situations such as fibromaes.
In one embodiment, melting medium is steam, can shrink after cooling.Can expand with cryogen or the hot fluid used in heating ablation keeps compared with constancy of volume, when steam becomes water, volume can diminish.For both cryogen and hot fluid, increase energy delivery and can increase and melt medium volume, and then need to remove the mechanism of melting medium, otherwise the supply of medicine can produce complication.But steam becomes water after cooling and occupies obviously little volume; Therefore, energy delivery increases the volume melting medium with residue to be increased irrelevant, thus melts medium without the need to removing further.This reduces the risk of leaking heat energy via fallopian tube 74 or cervix uteri 71 further, thus reduces the risk of health tissues near hot injury.
In one embodiment, positioning attachment must separate with ablation areas and be greater than 0.1mm, is preferably 1mm, is more preferably the distance of 1cm.In another embodiment, positioning attachment can be arranged in ablation areas, only otherwise cover very large surf zone.Melt for endometrial, do not need to melt the therapeutic effect all organized to obtain expection.
In one embodiment, preferred far-end positioning attachment be near central body zone location do not cover gauze.In one embodiment, preferred positioner is the gauze covered, and it is drawn into cervix uteri, is centered by device, and closes cervix uteri.One or more this positioner may be favourable for dissecting change in compensation uterus.Proximally-located device is preferably oval, has the major axis of 0.1mm-10cm (being preferably 1-5cm) and the minor axis of 0.1mm-5cm (being preferably 0.5cm-1cm).Far-end positioner is preferably circular, has 0.1mm-10cm, is preferably the diameter of 1cm-5cm.
Fig. 8 illustrates and utilizes the hole performed in nasal passage according to the ablating device of one embodiment of the present invention to melt.Show and comprise nostril 81, nasal passage 82, sinus frontalis 83, sieve hole 84, and the ill nasal passage of hole epithelial cell 85 and the cross-sectional view of nasal sinuses.Conduit 86 inserts in sinus frontalis 83 or sieve hole 84 through nostril 81 and nasal passage 82.
In one embodiment, conduit 86 has two setting elements: taper setting element 87 and dish type setting element 88.Setting element 87 is tapers, has the dielectric film covering taper setting element.Conduit 86 is positioned at the central authorities of hole opening 80 by conical component 87, and dielectric film prevents from heat energy or melt medium being overflowed by opening.Second dish type setting element 88 launches in sinus frontalis chamber 83 or sieve hole chamber 84, conduit 86 is positioned at the centre in arbitrary hole chamber.Melt medium 8 by inlet 89, medium 8 will be melted and be transported to equably in hole chamber.The predetermined length " l " of the section of melting conduit and the diameter " d " of setting element 88 allow to estimate chamber size, and for calculating the amount of the heat energy melted needed for ill hole epithelial cell 85.Alternatively, the temperature sensor 888 configured near ill hole epithelial cell 85 can control the conveying of melting medium 8.In one embodiment, melting medium is steam, can shrink after cooling.This reduces the risk of leaking heat energy further, thus reduces the risk of health tissues near hot injury.In one embodiment, the size range of setting element is similar with the size range in the application of in uterus film, and preferred maximum magnitude is its half.Alternatively, utilize multiple infrared ray, electromagnetism, mapping is taken a picture in the local of sound or radio frequency energy emitter and sensor, can be used for defining the shape in the size in chamber and the chamber of or distortion irregular because of situations such as nasal polyps.
Fig. 9 illustrates melting of the bronchus that performs in lung system according to the ablating device of one embodiment of the present invention and bulla.Show and there is bronchus 91, normal alveolar 92, bulla pathological changes 93, and the cross section of the lung system of bronchus abscess 94.
In one embodiment, conduit 96 inserts bronchus 91 by bronchoscopic passage and and then enters into bulla pathological changes 93.Conduit 96 has two setting elements: taper setting element 97 and dish type setting element 98.Setting element 97 is tapers, has dielectric film cover.Conduit 96 is positioned at the central authorities of bronchus 91 by conical component 97, and dielectric film prevents from heat energy or melt medium being escaped in normal bronchial by opening.Second dish type setting element 98 launches in bulla chamber 93, conduit 96 is positioned at the centre in bulla chamber 93.Melt medium 9 to be transported to equably in cavity by inlet 99.The predetermined length " l " of conduit 96 section of melting and the diameter " d " of setting element 98 allow to estimate bronchial lumen size, and for calculating the amount of the heat energy melted needed for ill bulla chamber 93.Alternatively, the radiology of Thoracic CT scan or NMR (Nuclear Magnetic Resonance)-imaging (MRI) can be utilized to estimate to calculate the size in chamber.Alternatively, temperature sensor is arranged near the surface in bulla chamber 93, to control the conveying of melting medium 9.In one embodiment, melting medium is at steam, can shrink after the cooling period.This further reduces heat energy and leak into risk in normal bronchial, thus reduce the risk of normal structure near hot injury.
In one embodiment, positioning attachment must separate more than 0.1mm with ablation areas, is preferably 1mm, is more preferably the distance of 1cm.In another embodiment, positioning attachment can be arranged in ablation areas, only otherwise occupy very large surf zone.
In one embodiment, preferably there are two positioning attachments.In another embodiment, use endoscope as a fixing point of a setting element.Positioner is 0.1mm-5cm (being preferably 1mm-2cm).Far-end positioner is preferably circular, has 0.1mm-10cm, is preferably the diameter of 1-5cm.
In another embodiment of bronchus abscess 94, conduit 96 inserts bronchus 91 by the passage of bronchoscope 95 and and then enters into bronchus abscess 94.Setting element 98 is dish types, has dielectric film cover.Setting element 98 is by the central authorities of catheter positioning in bronchus 91, and dielectric film prevents from heat energy or melt medium being escaped in normal bronchial by opening.Melt medium 9 in on-circular mode by inlet 99 so that medium transport will be melted equably in bronchus abscess 94.The predetermined length " l " of catheter ablation section and the diameter " d " of setting element 98 are used for calculating the amount of the heat energy melted needed for bronchus abscess 94.
Figure 10 illustrates and utilizes the device according to one embodiment of the present invention to perform ablation of prostate to the increase prostate in male urinary system.Show the prostate 101, the bladder 102 that comprise increase, and the cross section of the male genitourinary tract of urethra 103.The prostate 101 that urethra 103 is increased extrudes.Ablation catheter 105 is by being placed in the cystoscope 104 of the urethra 103 of barrier far-end.Setting element 106 launches with by the central authorities of catheter positioning at urethra 103, and insulating needle 107 is through to thrust prostate 101.Steam melts medium 108 by insulating needle 107, thus melts ill prostata tissue, thus prostate is shunk.
In one embodiment, positioning attachment must separate the distance that ablation areas is greater than 0.1mm, is preferably 1mm-5mm, is no more than 2cm.In another embodiment, positioning attachment can launch in bladder, and is drawn rearward in the cervical region of urethra opening/bladder, thus A/C.In one embodiment, positioner is 0.1mm-10cm.
Figure 11 illustrates to utilize and melts the fibroma that womb performs according to the ablating device of one embodiment of the present invention.Show and comprise fibroma uteri 111, uterus 112, and the cross section of the female genital tract of cervix uteri 113.Ablation catheter 115 is by being placed in the metroscope 114 of intrauterine fibroma uteri 111 far-end.Ablation catheter 115 has puncture tip 120, contributes to thrusting fibroma uteri 111.Setting element 116 launches with the central authorities of catheter positioning in fibroma 111, and insulating needle 117 is through to pierce through fibroid tissue 111.Steam melts medium 118 by pin 117, thus melts fibroma uteri 111, and fibroma is shunk.
Figure 12 illustrates and uses the steam transmission system of radio heater steam to be supplied to the ablating device according to one embodiment of the present invention.At an embodiment, what use steam to use as ablating device of the present invention melts medium.Radio heater 64 is positioned near the pressure vessel 42 containing liquid 44.Radio heater 64 heating container 42, and container 42 heating liquid 44.Liquid 44 temperature raises and starts evaporation, makes the pressure increase in container 42.Can, by providing the thermal switch 46 for controlling resistance heater 64, the pressure in container 42 be kept relative stability.Once the temperature of liquid 44 reaches predetermined temperature, then thermal switch 46 cuts off radio heater 64.The steam that produces in release pressure container 42 can be carried out by control valve 50.When steam amount discharge container 42, produce Pressure Drop in a reservoir, temperature is reduced.Thermal switch 46 measures temperature to be reduced, and radio heater 64 restarts heating liquid 44.In one embodiment, the target temperature of container 42 can be arranged to about 108 DEG C, continuous print steam supply is provided.When steam is released, produces Pressure Drop, make the temperature of steam be reduced to about 90-100 DEG C.When the liquid 44 in container 42 evaporates, steam amount discharge container 42, the amount of liquid 44 slowly reduces.Alternatively, container 42 is started by controller 24 with the pump 49 be transported to by more liquid 44 in container 42 after reducing at the pressure sensed in container 42 or temperature, is connected to the bin 43 comprising liquid 44.
Steam Transportation conduit 16 is connected to container 42 via Liquid connector 56.When control valve 50 is opened, container 42 is connected to delivery conduit 16 via adapter 56 fluid.Gauge tap 60 can be used for opening and closing steam Transportation by actuator 48.Such as, gauge tap 60 physically can open and close valve 50, to control the conveying of the vapor stream from container 42 by actuator 48.Switch 60 can be configured to other attribute controlling steam, such as direction, flow velocity, pressure, volume, sprayed fiber concrete or other parameter.
As the replacement scheme or the additional means that physically control steam attribute, switch 60 can also with controller 24 electric connection.Controller 24 controls radio heater 64, and radio heater 64 controls the attribute of steam in response to the actuating of operator to switch.In addition, controller 24 can control the valve temperature that is associated with conduit 16 or container 42 or pressure regulator.Flow velocity, the pressure of steam carried via conduit 16 can be measured by use traffic meter, or volume.Controller 24 controls the temperature and pressure in container 42, and flows through time of steam of control valve 50, speed, flow and volume.These parameters can be set by operator 11.Utilize the target temperature of 108 DEG C, the pressure produced in container 42, can be equivalent to 25 pound per square inches (psi) (1.72 bar).
Figure 13 illustrates and uses the steam transmission system of resistance heater steam to be supplied to the ablating device according to one embodiment of the present invention.At an embodiment, what used as ablating device of the present invention by produced steam melts medium.Resistance heater 40 is positioned near pressure vessel 42.Container 42 is containing liquid 44.Resistance heater 40 heating container 42, and container 42 heating liquid 44.Therefore, liquid 44 heats and starts evaporation.When liquid 44 starts to evaporate, the steam in container 42 makes the pressure increase in container.Can, by providing the thermal switch 46 for controlling resistance heater 40, the pressure in container 42 be kept relative stability.When the temperature of liquid 44 reaches predetermined temperature, thermal switch 46 cuts off resistance heater 40.The steam that produces in release pressure container 42 can be carried out by control valve 50.When steam amount discharge container 42, in container 42, produce Pressure Drop.Pressure Drop in container 42 makes temperature reduce.Thermal switch 46 measures temperature to be reduced, and resistance heater 40 restarts heating liquid 44.In one embodiment, the target temperature of container 42 can be arranged to about 108 DEG C, continuous print steam supply is provided.When steam is released, produces Pressure Drop, make the temperature of steam be reduced to about 90-100 DEG C.When the liquid 44 in container 42 evaporate and steam amount discharge container 42 time, the amount of liquid 44 slowly reduces.Container 42 is started by controller 24 with the pump 49 be transported to by more liquid 44 in container 42 after reducing at the pressure sensed in container 42 or temperature, is connected to another bin 43 comprising liquid 44.
Steam Transportation conduit 16 is connected to container 42 via Liquid connector 56.When control valve 50 is opened, container 42 is connected to delivery conduit 16 via adapter 56 fluid.Gauge tap 60 can be used for opening and closing steam Transportation by actuator 48.Such as, gauge tap 60 physically can open and close valve 50, to control the conveying of the vapor stream from container 42 by actuator 48.Switch 60 can be configured to other attribute controlling steam, such as direction, flow velocity, pressure, volume, sprayed fiber concrete or other parameter.As the replacement scheme or the additional means that physically control steam attribute, switch 60 can also with controller 24 electric connection.Controller 24 controlling resistance heater 40, and resistance heater 40 controls the attribute of steam in response to the actuating of operator to switch 60.In addition, controller 24 can control the valve temperature that is associated with conduit 16 or container 42 or pressure regulator.Flow, the pressure of steam carried via conduit 16 can be measured by use traffic meter 52, or volume.Controller 24 controls the temperature and pressure in container 42, and flows through time of steam of control valve 50, speed, flow and volume.These parameters can be set by operator 11.Utilize the target temperature of 108 DEG C, the pressure produced in container 42, can be equivalent to 25 pound per square inches (psi) (1.72 bar).
Apparatus and method of the present invention can be used to realize controlled focus or circumferential ablation to destination organization, carry out varying depth in the healing mode completely that again can form epithelium.Dosage and the mode of adjustment for the treatment of can be come based on the type of tissue and the required degree of depth melted.This ablating device not only may be used for treatment Barrett esophagus, esophagus dysplasia, flat polyp of colon, gastrointestinal hemorrhage pathological changes, endometrial ablation, pulmonary ablation, any mucosa, tela submucosa or periphery pathological changes can also be used for the treatment of, such as inflammatory lesion, tumor, polyp and vascular pathological changes.Ablating device also can be used for treating the focus of health hollow organ or Hollow Body passage or periphery mucosa or tela submucosa pathological changes.Hollow organ can be the vascular structures such as gastrointestinal tract, pancreas road, reproductive tract, respiratory tract or such as blood vessel.Ablating device can by endoscope, lonizing radiation, surgically or directly visually arrange.In each embodiment, wireless endoscope or ultimate fibre endoscope can be incorporated into the part as device in device.
Although described in this article and shown illustrative embodiments of the present invention, but it should be understood that these embodiments are only for purposes of illustration.Those of ordinary skill in the art it should be understood that without departing from the spirit and scope of the present invention, can also carry out various distortion to form and details.

Claims (17)

1., to the device that endometrial tissue melts, comprising:
A. conduit, it has the axle that steam can pass therethrough;
B. be connected to the first setting element of the axle of described conduit in primary importance, wherein said first setting element is configured to make described catheter positioning in the distance of fixing apart from described endometrial tissue to be ablated; And
C. input port, described input port is communicated with to receive described steam in second position and with the axial flow body of described conduit, and wherein said axle comprises one or more port, and described steam can be discharged from described axle by described one or more port,
It is characterized in that, the flowing of described steam is by Microprocessor S3C44B0X, and the preliminary dimension of the length of described conduit and described first setting element is used to the amount melting required heat energy calculating described endometrial tissue.
2. device as claimed in claim 1, wherein said first setting element is at least one in taper, dish type or the free forming shape suitable with the shape in the uterus of patient.
3. device as claimed in claim 1, wherein said preliminary dimension is for determining the size in the uterus to be ablated of patient.
4. device as claimed in claim 1, wherein said first setting element comprises dielectric film, and wherein said dielectric film is configured to prevent heat energy from overflowing.
5. device as claimed in claim 1, also comprise at least one in sound, electromagnetism, infrared ray or radio-frequency (RF) energy sensor, wherein said sensor is for measuring the size in the uterus of patient.
6. device as claimed in claim 1, wherein said port is between described primary importance and the described second position.
7. device as claimed in claim 1, also comprises at least one temperature sensor.
8. device as claimed in claim 7, wherein said temperature sensor is for controlling the conveying of described steam.
9. device as claimed in claim 1, wherein said first setting element is insulation gauze.
10. device as claimed in claim 1, wherein said first setting element comprises the round of diameter between 0.01mm and 10cm.
11. devices as claimed in claim 1, wherein said first setting element is oval, and the major axis of wherein said ellipse is between 0.01mm and 10cm, and minor axis is between 0.01mm and 9cm.
12. 1 kinds of devices melted endometrial tissue, comprising:
A. conduit, it has therefrom can the quill shaft of delivering vapor;
B. be connected to the first setting element of the quill shaft of described conduit in primary importance, wherein said first setting element is configured to the distance making described catheter positioning predetermined in the surface apart from hollow tissue;
C. be integrally formed in the multiple ports on the quill shaft of described conduit, wherein steam can be released and be directed to endometrial tissue to be ablated from described port; With
D. at least one temperature sensor,
Wherein said first setting element has preliminary dimension, and wherein said size is for determining the size in the uterus of patient, and for calculating the amount melting heat energy needed for described endometrial tissue.
13. devices as claimed in claim 12, at least one temperature sensor wherein said is for controlling the conveying of described steam.
14. devices as claimed in claim 12, wherein said first setting element comprises dielectric film, and wherein said dielectric film is configured to prevent heat energy from overflowing.
15. devices as claimed in claim 12, wherein said first setting element is insulation gauze.
16. devices as claimed in claim 12, wherein said first setting element comprises the round of diameter between 0.01mm and 10cm.
17. devices as claimed in claim 12, wherein said first setting element is oval, and the major axis of wherein said ellipse is between 0.01mm and 10cm, and minor axis is between 0.01mm and 9cm.
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